Evaluation of a Website to Improve Depression Literacy in Adoldescents

July 26, 2022 updated by: Ellen Greimel, Ludwig-Maximilians - University of Munich

Evaluating the Efficacy and the Acceptability of the Website "Ich Bin Alles" to Improve Depression Literacy in Adolescents

The aim of this study is to evaluate the efficacy and acceptability of the website "ich bin alles" (https://www.ich-bin-alles.de/) to improve depression literacy (knowledge about depression, which aid the recognition, treatment or prevention of depression) in healthy adolescents. The investigators will examine whether the website improves depression literacy in healthy adolescents aged 12 to 18 years. The investigators will also assess the acceptability of the website among adolescents.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Few young people with major depressive disorder seek professional treatment in time. Concerns about social stigma, confidentiality, and limited knowledge about mental health conditions, such as depression, or mental health services are some of the main barriers to seek treatment. To address these problems, we developed an evidence-based website "ich bin alles" (https://www.ich-bin-alles.de/) to improve depression literacy.

To improve depression literacy, the website provides general information about depression as psychiatric disorder in adolescents (e.g., symptoms, causes, course and treatment of depression). Furthermore, the website provides information about self-help strategies for depression and prevention of depression; i.e., strategies for promoting mental health (e.g., reducing stress, doing exercise, undertaking positive activities), which are meant to serve as an addition to professional treatments of depression or to promote mental health in adolescents.

Target groups of the website are adolescents aged 12 to 18 years seeking help for depression, as well as healthy adolescents seeking information about mental health promotion or depression. Easy access to information about depression would make early recognition of depression more likely and engage young people to seek help for depression.

Since the website targets two different groups, the investigators will evaluate the website accordingly:

Target group 1: Adolescents with a major depressive disorder (acute or remitted) Target group 2: Healthy Adolescents (no mental health condition) The current study will focus on target group 2. A study focusing on target group 1 can be found in a separately registered clinical trial on clinicaltrials.gov.

The primary aim of this study is to evaluate the efficacy and acceptability of the website "ich bin alles" (https://www.ich-bin-alles.de/) to improve depression literacy in healthy adolescents.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Munich, Bayern, Germany, 80336
        • Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Intelligence quotient (IQ) of ≥ 80

Exclusion Criteria:

  • Current diagnosis of a mental disorder
  • Remitted depressive disorder
  • Insufficient knowledge of German

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group 2 - General information about depression
Exposure to general information about depression
Other: General information about depression

Before starting the intervention, the participants are told that they will be shown parts of a website about depression. The participants are instructed to carefully attend to the website (e.g., to read the text precisely, to hear attentively to the podcasts and to view carefully the videos and images on the website). The time window spent for the reception of each part of the website are fixed.

The participants in this intervention group will only be shown parts of the website regarding general information about depression
Experimental: Intervention Group 1 - Strategies for promoting mental health
Exposure to information about strategies for promoting mental health
Other: Strategies for promoting mental health

Before starting the intervention, the participants are told that they will be shown parts of a website about depression. The participants are instructed to carefully attend to the website (e.g., to read the text precisely, to hear attentively to the podcasts and images on the website). The time window spent for the reception of each part of the website are fixed.

The participants in this intervention group will only be shown parts of the website regarding strategies for promoting mental health

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Depression Literacy - Depression as psychiatric disorder
Time Frame: Pre-Test, Post-Test (within 2 hours), Follow-Up 1 (Week 2), Follow-Up 2 (Week 4)
This self-designed questionnaire is a self-report inventory to assess knowledge of depression as psychiatric disorder (frequency and comorbidities, treatment, symptoms, causes and course of depression; 27 items), with higher scores indicating more knowledge of depression as psychiatric disorder. Participants will complete this self-designed questionnaire at pre-test, post-test and the two follow-ups to determine change in knowledge of depression as psychiatric disorder
Pre-Test, Post-Test (within 2 hours), Follow-Up 1 (Week 2), Follow-Up 2 (Week 4)
Depression Literacy - Strategies for promoting mental health
Time Frame: Pre-Test, Post-Test (within 2 hours), Follow-Up 1 (Week 2), Follow-Up 2 (Week 4)
This self-designed questionnaire is a self-report inventory to assess knowledge of strategies for promoting mental health (exercise, dealing with problems and stress, positive attitude, postive activities and social contacts; 27 items), with higher scores indicating more knowledge of strategies for promoting mental health. Participants will complete this self-designed questionnaire at pre-test, post-test and the two follow-ups to determine change in knowledge of strategies for promoting mental health.
Pre-Test, Post-Test (within 2 hours), Follow-Up 1 (Week 2), Follow-Up 2 (Week 4)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Aesthetics of Websites Inventory Short Version (VisAWI-S)
Time Frame: Post-Test (within 2 hours)
The short version of the Visual Aesthetics of Websites Inventory (VisAWI-S) is self-report inventory to assess the evaluation of the website's design - especially the perceived visual aesthetics. Participants indicated their response to the four items (e.g., "The layout appears professionally designed") on a seven-point Likert scale (ranging from 1 "do not agree at all" to 7 "do fully agree")
Post-Test (within 2 hours)
Overall reception of the website
Time Frame: Post-Test (within 2 hours)
The overall reception of the website as measured with a self-designed questionnaire
Post-Test (within 2 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ludwig-Maximilians - University of Munich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Prof. OTTO Beisheim Stiftung (Germany)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20115_2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data in our study contains sensitive patient information, such as sociodemographic information and comorbidities. Since patients could possibly be identified by making our raw data publicly available, ethical principles of protecting patient confidentiality would be breached. Aggregated group data can be made available upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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